Prediabetic StatePROVEN-DIANCT06426277
Effectiveness of the Brazilian Diabetes Prevention Program
A study testing PROVEN-DIA Hybrid Lifestyle Intervention and TelePROVEN-DIA Lifestyle Intervention in people with Prediabetic State and Pre Diabetes, run by Beneficência Portuguesa de São Paulo at 2 sites in Brazil.
Trial summary
The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetic State, Pre Diabetes
- What is being tested?
- PROVEN-DIA Hybrid Lifestyle Intervention and TelePROVEN-DIA Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,305 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Dec 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years or older (no maximum age for being eligible)
- Have a body mass index (BMI) between 18,5 and 34,9kg/m²
- Have, at least, one electronic device (includes any of the following devices):
- Computer
- Laptop/notebook
- Tablet
Show all 10Show fewer
- Smartphone
- Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment/randomization/intervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months
- Living near the research center (at maximum 60 minutes)
- Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.
Who cannot join
- Diagnosis of Diabetes Mellitus (including current or recent use, within three months, of glucose-lowering medication)
- Underlying disease likely to limit life expectancy and/or increase the risk of interventions influencing the risk of developing T2D
- Diagnosis of Renal Disease
- Diagnosis of Pulmonary Disease
- Gastrointestinal Disease
- Secondary prevention for Cardiovascular Disease
Show all 24Show fewer
- Endocrine Diseases
- Weight loss exceeding 10% in the last 6 months (except postpartum-related)
- Uncontrolled Hypertension
- Diagnosis of Polycystic Ovary Syndrome (self-reported)
- Patients undergoing treatment for Tuberculosis (except those using isoniazid [INH] as prophylaxis)
- Presence of diseases that may severely reduce life expectancy or the ability to participate in the study
- Pregnant or breastfeeding women
- Severe psychiatric disorders that, in the opinion of the clinical team, hinder participation in the program
- Acute or chronic excessive alcohol consumption
- Congestive Heart Failure (CHF) with a New York Heart Association Functional Class (NYHA) > 2
- Need for referral to a cardiologist according to the Physical Activity Readiness Questionnaire (PAR-Q)
- Current or recent participation (within the last six months) in another clinical trial that impacts the interventions and/or is associated with the study outcomes (in case of doubt, contact the coordinating center)
- Likely relocation away from the research collaborating center within the next 3 years
- Another household member is a participant or a team member of the PROVEN-DIA study
- Unwillingness to accept treatment assignment by randomization and/or refusal to participate in the study (signing the Informed Consent Form)
- Continuous use of the following medications:
- Corticosteroids other than topical, ophthalmic, or inhaled preparations Antineoplastic agents Psychoactive agents Other medications.
- Participant from the pilot Randomized Clinical Trial (Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Clínicas de Goiás - UFG
Goiânia, Goiás
Ana Paula Perillo, PhD, 55 (62) 98414-6969, anapaulaperillo@ufg.br
- Recruiting
Universidade Federal de Viçosa
Viçosa, Minas Gerais
Josefina Bressan, PhD, 55 31 98606-3903, jbrm@ufv.br
About this study
Official title: Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min/week), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.
Read the detailed description
This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).
- Conditions
- Prediabetic State, Pre Diabetes
- Being tested
- PROVEN-DIA Hybrid Lifestyle Intervention, Usual Care Lifestyle Guidance, TelePROVEN-DIA Lifestyle Intervention
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROVEN-DIA Hybrid Lifestyle InterventionBehavioural
Also called PROVEN-Dia
A structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change
Usual Care Lifestyle GuidanceBehavioural
Lifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions.
TelePROVEN-DIA Lifestyle InterventionBehavioural
Also called TelePROVEN-Dia
A structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change.
| Study group | Role | What they receive |
|---|---|---|
| Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support) | Experimental | The PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include healthy eating, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals.
Specifically, in this arm, PROVEN-DIA is delivered through a hybrid model combining in-person individual and group sessions with remote support contacts provided by trained Lifestyle Counselors and Lifestyle Coaches. Receives: Behavioral: PROVEN-DIA Hybrid Lifestyle Intervention |
| Brazilian Diabetes Prevention Program - TeleHealth (remote care) | Experimental | The PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals.
Specifically, in this arm, PROVEN-DIA is delivered exclusively through telehealth using videoconferencing and other remote communication technologies. Receives: Behavioral: TelePROVEN-DIA Lifestyle Intervention |
| Control Group | Active comparator | Participants allocated to the usual care control group receive the same lifestyle guidance content as the intervention groups, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. However, this guidance is not delivered through a structured behavior change program. Individual visits are scheduled every six months according to a standardized study protocol. Receives: Behavioral: Usual Care Lifestyle Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 2 diabetes mellitus (T2DM)
to analyze the incidence of type 2 diabetes mellitus
Measured: 36 months
Secondary outcomes (32)
Mean value of Glycated Hemoglobin level (HbA1c in %)
to compare mean HbA1c(%) obtained through laboratory exams/tests between groups
Measured: 6, 12, 24 and 36 months
Mean value of Fasting Blood Glucose (mg/dL)
to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups
Measured: 6, 12, 24 and 36 months
Number of Participants with controlled Fasting blood glucose (<126mg/dL)
to compare the proportion of individuals with controlled blood glucose (<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication
Measured: 6, 12, 24 and 36 months
Number of Participants with controlled Glycated Hemoglobin level (<6.4%)
to compare the proportion of individuals with HbA1c (<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication
Measured: 6, 12, 24 and 36 months
body weight
to compare mean weight (kg) between groups
Measured: 6, 12, 24 and 36 months
Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained by International Physical Activity Questionnaire
to compare the proportion of individuals who are physically active (>150 minutes of moderate to vigorous physical activity) and inactive (<150 minutes of moderate to vigorous physical activity) between groups
Measured: 6, 12, 24 and 36 months
Minutes spent on moderate-to-vigorous physical activity
to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups
Measured: 6, 12, 24 and 36 months
Moderate-to-vigorous physical activity and sedentary behavior
to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior
Measured: 6, 12, 24 and 36 months
Physical activity
to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week
Measured: 6, 12, 24 and 36 months
Sedentary behavior
to compare the proportion of sedentary individuals
Measured: 6, 12, 24 and 36 months
Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R))
to compare mean score of the Diet Quality Index Revised (DQI-R) between groups Minimum: 0 Maximum: 100 When higher the score, better the quality of diet
Measured: 6, 12, 24 and 36 months
Mean of kcal from ultra processed food intake
to compare the mean caloric intake (kcal) from ultra-processed foods obtained through two 24-hour Dietary Recall applied within a period of fifteen days
Measured: 6, 12, 24 and 36 months
Delta value (Change score from baseline to 6, 12, 24 and 36 months) for each domain of Quality of life obtained through Short Form Health Survey (SF-36)
to analyze the quality of life based on delta value of the eight domains (Functional capacity, Physical aspects, Pain, General health status, Vitality, Social aspects, Emotional aspects and Mental health) When higher the score, better the quality of life related to the assessed domain
Measured: 6, 12, 24 and 36 months
Cost
To compare the cost of interventions. To estimate healthcare system costs, we will consider only direct medical costs, which include screening costs, intervention costs, and costs of healthcare service utilization. To estimate social costs, we will consider not only direct medical costs but also non-medical direct costs, such as transportation, food, and accommodation expenses reported by participants when seeking medical assistance, as well as time spent traveling to and participating in group sessions. Additionally, we will include indirect costs, calculated based on the assumption that each necessary hospitalization results in a loss of 9 hours of paid work and each outpatient visit results in a loss of half a day (4.5 hours) of paid work
Measured: 36 months
Scholarity
To analyze the correlation between years of study and the incidence of type 2 diabetes
Measured: 36 months
Geo-Stratified Analysis
T2DM incidence across Brazillian five geographic regions (North, Northeast, Central-West (Midwest), Southeast, South)
Measured: 36 months
Household income
Association between T2DM incidence and individual Low or high income (accessed by ABEP - Critério Brasil 2022 questionnaire. A Brazilian validated questionnaire to evaluate Household income)
Measured: 36 months
Neighbourhood value
correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2)
Measured: 36 months
Mean value of BMI (kg/m2)
to compare mean BMI (kg/m2) between groups
Measured: 6, 12, 24 and 36 months
Number of Participants in use of hypoglycemic medication
to compare the proportion of individuals in use of hypoglycemic medication
Measured: 6, 12, 24 and 36 months
delta body weight
to compare mean delta weight (kg) between groups (delta = final mean weight - baseline mean weight)
Measured: 6, 12, 24 and 36 months
delta glycemia
To compare the mean delta glycemia (mg/dL) between groups:
Delta = Mean glycemia at the final measurement - Mean glycemia at baseline
This approach evaluates the difference in blood glucose changes across the groups over the study period, reflecting the intervention's impact on glycemic control.
Measured: 6, 12, 24 and 36 months
delta HbA1c (%)
To compare the mean delta HbA1c (%) between groups:
Delta = Mean HbA1c at the final measurement - Mean HbA1c at baseline
This approach evaluates the difference in blood glucose changes across the groups over the study period, reflecting the intervention's impact on glycemic control.
Measured: 6, 12, 24 and 36 months
delta Insulin (μU/mL)
To compare the mean delta Insulin (μU/mL) between groups:
Delta = Mean Insulin at the final measurement - Mean Insulin at baseline
This approach evaluates the difference in Insulin changes across the groups over the study period, reflecting the intervention's impact on glycemic control.
Measured: 6, 12, 24 and 36 months
delta HOMA-IR (homeostasis model assessment-estimated insulin resistance)
To compare the mean delta HOMA-IR between groups:
Delta = Mean HOMA-IR at the final measurement - Mean HOMA-IR at baseline
HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is calculated using the following formula:
HOMA-IR = [Fasting insulin (μU/mL) × Fasting glucose (mg/dL)] / 405
This approach evaluates the difference in insulin resistance changes across the groups over the study period, reflecting the intervention's impact on metabolic control.
Measured: 6, 12, 24 and 36 months
delta HOMA-Beta *homeostasis model assessment of β-cell function)
To compare the mean delta HOMA-Beta between groups:
Delta = Mean HOMA-Beta at the final measurement - Mean HOMA-Beta at baseline
HOMA-Beta (Homeostatic Model Assessment of Beta-Cell Function) is calculated using the following formula:
HOMA-Beta = [360 × Fasting insulin (μU/mL)] / [Fasting glucose (mg/dL) - 63]
This approach evaluates the difference in beta-cell function changes across the groups over the study period, reflecting the intervention's impact on pancreatic function.
Measured: 6, 12, 24 and 36 months
delta PSQI-BR scores (Pittsburgh Sleep Quality Index - Brazilian version)
To compare the mean delta PSQI-BR scores between groups:
Delta = Mean PSQI-BR score at the final measurement - Mean PSQI-BR score at baseline
The PSQI-BR (Pittsburgh Sleep Quality Index - Brazilian version) is a validated instrument used to assess sleep quality. It generates a total score based on seven components:
Subjective sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleeping medications Daytime dysfunction Each component is scored from 0 to 3, and the total PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality.
This approach evaluates the difference in sleep quality changes across the groups over the study period, reflecting the intervention's impact on sleep outcomes.
Measured: 6, 12, 24 and 36 months
delta PSS-10 (Perceived Stress Scale - 10-item Brazilian version)
To compare the mean delta PPS-10 scores between groups:
Delta = Mean PPS-10 score at the final measurement - Mean PPS-10 score at baseline
The PPS-10 (Perceived Stress Scale - 10-item Brazilian version) is a validated instrument used to assess perceived stress over the last month. It consists of 10 questions scored on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often).
The total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
This approach evaluates the difference in perceived stress levels across the groups over the study period, reflecting the intervention's impact on stress outcomes.
Measured: 6, 12, 24 and 36 months
mean alcohol consumption (g/day)
To compare the mean alcohol consumption (g/day) between groups.
Alcohol consumption will be assessed using a specific Alcohol Frequency Questionnaire, which records the type, frequency, and quantity of alcoholic beverages consumed. The total alcohol intake will be calculated in grams per day using the formula:
Grams of alcohol/day = (Volume consumed [mL] × Alcohol content [%] × 0.8) / Days
Where:
Volume consumed is the reported quantity of alcoholic beverage. Alcohol content [%] is the average alcohol percentage for each beverage type. 0.8 is the density of pure ethanol.
This approach evaluates the difference in perceived stress levels across the groups over the study period, reflecting the intervention's impact on stress outcomes.
Measured: 6, 12, 24 and 36 months
proportion of smokers
To compare the proportion of smokers between groups at the end of the study:
Smoking status will be assessed by self-report as either:
Current smokers Former smokers Never smoked
The proportion of smokers will be calculated as:
Proportion of smokers (%) = (Number of smokers / Total participants in the group) × 100
The comparison will focus on the proportion of current smokers in each group at the study's conclusion to evaluate the intervention's impact on smoking prevalence.
Measured: 6, 12, 24 and 36 months
mean number of cigarettes smoked per day
To compare the mean number of cigarettes smoked per day between groups at the end of the study:
Smoking behavior will be assessed by participants self-report the average number of cigarettes smoked per day.
The mean number of cigarettes smoked per day for each group will be calculated as:
Mean number of cigarettes/day = (Total number of cigarettes smoked by participants in the group) / (Number of participants who are current smokers)
This comparison will evaluate the intervention's impact on the average smoking intensity among individuals who continue to smoke.
Measured: 6, 12, 24 and 36 months
mean scores of the eight SF-36 quality of life domains
To compare the mean scores of the eight SF-36 quality of life domains between groups at the end of the study:
Quality of life will be assessed using the SF-36 Health Survey, which evaluates eight domains:
Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health
Each domain generates a score ranging from 0 to 100, where higher scores indicate better quality of life.
The mean scores for each domain will be calculated as:
Mean domain score = (Sum of scores for all participants in the group) / (Number of participants in the group)
This comparison will assess differences in quality of life between groups at the study's conclusion, reflecting the intervention's impact across various health dimensions.
Measured: 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beneficência Portuguesa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela C Bersch-Ferreira, PhD, Principal investigator, Hospital Beneficência Portuguesa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426277
- Sponsor's protocol ID
- PROVEN-DIA ECR
- Acronym
- PROVEN-DIA
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)
- ClinicalTrials.gov ID
- NCT06426277
- Acronym / sponsor ID
- PROVEN-DIA / PROVEN-DIA ECR
- Conditions
- Prediabetic State, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,305 participants (estimated)
- Lead sponsor
- Beneficência Portuguesa de São PauloUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min/week), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.
Detailed description
This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support) | Experimental | Behavioral: PROVEN-DIA Hybrid Lifestyle InterventionThe PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include healthy eating, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals. Specifically, in this arm, PROVEN-DIA is delivered through a hybrid model combining in-person individual and group sessions with remote support contacts provided by trained Lifestyle Counselors and Lifestyle Coaches. |
| Brazilian Diabetes Prevention Program - TeleHealth (remote care) | Experimental | Behavioral: TelePROVEN-DIA Lifestyle InterventionThe PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals. Specifically, in this arm, PROVEN-DIA is delivered exclusively through telehealth using videoconferencing and other remote communication technologies. |
| Control Group | Active comparator | Behavioral: Usual Care Lifestyle GuidanceParticipants allocated to the usual care control group receive the same lifestyle guidance content as the intervention groups, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. However, this guidance is not delivered through a structured behavior change program. Individual visits are scheduled every six months according to a standardized study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be 18 years or older (no maximum age for being eligible)
- Have a body mass index (BMI) between 18,5 and 34,9kg/m²
- Have, at least, one electronic device (includes any of the following devices):
- Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment/randomization/intervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months
- Living near the research center (at maximum 60 minutes)
Key exclusion criteria (24 listed)
- Diagnosis of Diabetes Mellitus (including current or recent use, within three months, of glucose-lowering medication)
- Underlying disease likely to limit life expectancy and/or increase the risk of interventions influencing the risk of developing T2D
- Diagnosis of Renal Disease
- Diagnosis of Pulmonary Disease
- Gastrointestinal Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROVEN-DIA Hybrid Lifestyle InterventionAlso: PROVEN-DiaA structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change | Behavioural | Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support) |
| Usual Care Lifestyle GuidanceLifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions. | Behavioural | Control Group |
| TelePROVEN-DIA Lifestyle InterventionAlso: TelePROVEN-DiaA structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change. | Behavioural | Brazilian Diabetes Prevention Program - TeleHealth (remote care) |
Primary outcome
Incidence of type 2 diabetes mellitus (T2DM)
Time frame: 36 months
to analyze the incidence of type 2 diabetes mellitus
32 secondary outcomes
Mean value of Glycated Hemoglobin level (HbA1c in %)
Time frame: 6, 12, 24 and 36 months
Mean value of Fasting Blood Glucose (mg/dL)
Time frame: 6, 12, 24 and 36 months
Number of Participants with controlled Fasting blood glucose (<126mg/dL)
Time frame: 6, 12, 24 and 36 months
Number of Participants with controlled Glycated Hemoglobin level (<6.4%)
Time frame: 6, 12, 24 and 36 months
body weight
Time frame: 6, 12, 24 and 36 months
Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained by International Physical Activity Questionnaire
Time frame: 6, 12, 24 and 36 months
Minutes spent on moderate-to-vigorous physical activity
Time frame: 6, 12, 24 and 36 months
Moderate-to-vigorous physical activity and sedentary behavior
Time frame: 6, 12, 24 and 36 months
Physical activity
Time frame: 6, 12, 24 and 36 months
Sedentary behavior
Time frame: 6, 12, 24 and 36 months
Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R))
Time frame: 6, 12, 24 and 36 months
Mean of kcal from ultra processed food intake
Time frame: 6, 12, 24 and 36 months
Delta value (Change score from baseline to 6, 12, 24 and 36 months) for each domain of Quality of life obtained through Short Form Health Survey (SF-36)
Time frame: 6, 12, 24 and 36 months
Cost
Time frame: 36 months
Scholarity
Time frame: 36 months
Geo-Stratified Analysis
Time frame: 36 months
Household income
Time frame: 36 months
Neighbourhood value
Time frame: 36 months
Mean value of BMI (kg/m2)
Time frame: 6, 12, 24 and 36 months
Number of Participants in use of hypoglycemic medication
Time frame: 6, 12, 24 and 36 months
delta body weight
Time frame: 6, 12, 24 and 36 months
delta glycemia
Time frame: 6, 12, 24 and 36 months
delta HbA1c (%)
Time frame: 6, 12, 24 and 36 months
delta Insulin (μU/mL)
Time frame: 6, 12, 24 and 36 months
delta HOMA-IR (homeostasis model assessment-estimated insulin resistance)
Time frame: 6, 12, 24 and 36 months
delta HOMA-Beta *homeostasis model assessment of β-cell function)
Time frame: 6, 12, 24 and 36 months
delta PSQI-BR scores (Pittsburgh Sleep Quality Index - Brazilian version)
Time frame: 6, 12, 24 and 36 months
delta PSS-10 (Perceived Stress Scale - 10-item Brazilian version)
Time frame: 6, 12, 24 and 36 months
mean alcohol consumption (g/day)
Time frame: 6, 12, 24 and 36 months
proportion of smokers
Time frame: 6, 12, 24 and 36 months
mean number of cigarettes smoked per day
Time frame: 6, 12, 24 and 36 months
mean scores of the eight SF-36 quality of life domains
Time frame: 6, 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela C Bersch-Ferreira, PhD principal investigator
Hospital Beneficência Portuguesa de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROVEN-DIA Hybrid Lifestyle Intervention and TelePROVEN-DIA Lifestyle Intervention in people with Prediabetic State and Pre Diabetes, run by Beneficência Portuguesa de São Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela C Bersch-Ferreira, PhD ((55 11) 988295600, angelacbferreira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of type 2 diabetes mellitus (T2DM) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.